NCT04558710

Brief Summary

The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months. The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

May 10, 2023

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

September 16, 2020

Last Update Submit

May 9, 2023

Conditions

Type 1 DiabetesContinuous Glucose MonitoringChildrenGlucose Variability

Outcome Measures

Primary Outcomes (1)

  • Coefficient of variation

    1 year

Secondary Outcomes (2)

  • Time in Range

    1 year

  • Time Above Range

    1 year

Study Arms (2)

CGM

CGM users

SMBG

Non-CGM users

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and treated with insulin pump fo at least 3 months.

You may qualify if:

  • Type 1 diabetes for at least 6 months
  • Insulin pump user for at least 3 months
  • Treated with rapid or ultra-rapid acting insulin analogue

You may not qualify if:

  • Physical or psychological disease likely to interfere with normal conduct of the study
  • Untreated coeliac disease or thyroid disease
  • Current treatment with drugs known to interfere with glucose metabolism
  • Subject/carer's severe visual impairment
  • Subject/carer's severe hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty - University of Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

June 1, 2018

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

May 10, 2023

Record last verified: 2020-09

Locations

SL(1)